Full Press Release Details
Acadia Pharmaceuticals Reports
Third Quarter 2021 Financial Results
- 3Q21 net sales of $131.6 million, a 9% increase over 3Q20
- FDA meeting scheduled to discuss next steps towards a resubmission of the pimavanserin sNDA
SAN DIEGO, CA, November 8, 2021 - Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its financial results for the third quarter ended September 30, 2021.
"Our third-quarter results reflect volume growth across all channels and our strong relative performance underscores our commercial team's ability to drive sales of NUPLAZID in a challenging environment," said Steve Davis, Chief Executive Officer. "As we close out the year, we will meet with the FDA to discuss additional analyses supporting a potential resubmission of our sNDA for pimavanserin focused on specific subgroups of dementia. In addition, we look forward to announcing results from our ongoing Phase 3 LAVENDER study of trofinetide for the treatment of Rett syndrome."
Net sales of NUPLAZID (pimavanserin) were $131.6 million for the three months ended September 30, 2021, an increase of 9% as compared to $120.6 million reported for the three months ended September 30, 2020. For the nine months ended September 30, 2021 and 2020, Acadia reported net product sales of $353.4 million and $320.7 million, respectively.
Research and Development
Research and development expenses for the three months ended September 30, 2021 were $58.6 million, compared to $120.1 million for the same period of 2020. The decrease was largely due to decreased costs associated with the upfront consideration and transaction costs related to the acquisition of CerSci Therapeutics. For the nine months ended September 30, 2021 and 2020, research and development expenses were $172.5 million and $257.0 million. The decrease was largely due to the acquisition of CerSci Therapeutics and reduced development costs for trofinetide and the cessation of development of pimavanserin for major depressive disorder, partially offset by increased costs of our development activities for ACP-044.
Selling, General and Administrative
Selling, general and administrative expenses for the three months ended September 30, 2021 were $81.7 million, compared to $81.6 million for the same period of 2020. For the nine months ended September 30, 2021 and 2020, selling, general and administrative expenses were $290.1 million and $267.9 million, respectively. The increase was primarily due to increased advertising and promotional costs as well as an increase in personnel and related costs.
For the three months ended September 30, 2021, Acadia reported a net loss of $14.5 million, or $0.09 per common share, compared to a net loss of $84.7 million, or $0.54 per common share, for the same period in 2020. The net losses for the three months ended September 30, 2021 and 2020 included $15.5 million and $21.4 million, respectively, of non-cash stock-based compensation expense. For the nine months ended September 30, 2021, Acadia reported a net loss of $124.8 million, or $0.78 per common share, compared to a net loss of $214.8 million, or $1.37 per common share, for the same period in 2020. The net losses for the nine months ended September 30, 2021 and 2020 included $50.7 million and $63.2 million, respectively, of non-cash stock-based compensation expense.
Cash and Investments
At September 30, 2021, Acadia's cash, cash equivalents, and investment securities totaled $540.3 million, compared to $632.0 million at December 31, 2020.
2021 Financial Guidance
Conference Call and Webcast Information
Acadia management will review its third quarter financial results and operations via conference call and webcast today at 4:30 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 9213599). A telephone replay of the conference call may be accessed through November 22, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 9213599). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com under the investors section and will be archived there until December 6, 2021.
About NUPLAZID (pimavanserin)
Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID. NUPLAZID is not approved for dementia-related psychosis. In addition, Acadia is developing pimavanserin in other neuropsychiatric conditions.
Trofinetide is an investigational drug. It is a novel synthetic analog of the amino terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function. In the central nervous system, IGF-1 is produced by both of the major types of brain cells - neurons and glia. IGF-1 in the brain is critical for both normal development and for response to injury and disease. Trofinetide has been granted Fast Track Status and Orphan Drug Designation in the U.S. and Orphan Drug Designation in Europe for both Rett syndrome and Fragile X syndrome.
About Acadia Pharmaceuticals
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to: the potential opportunity for future growth in sales of NUPLAZID; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide; and guidance for full-year 2021 NUPLAZID net sales for Parkinson's disease psychosis and certain expense line items. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the uncertainty of future commercial sales and related items that would impact net sales during 2021, the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Acadia's annual report on Form 10-K for the year ended December 31, 2020 as well as Acadia's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenues | ||||||||||||||||
| Product sales, net | $ | 131,612 | $ | 120,577 | $ | 353,387 | $ | 320,748 | ||||||||
| Total revenues | 131,612 | 120,577 | 353,387 | 320,748 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Cost of product sales, license fees and royalties (1) | 6,682 | 4,801 | 16,580 | 15,249 | ||||||||||||
| Research and development (1) | 58,565 | 120,083 | 172,473 | 257,014 | ||||||||||||
| Selling, general and administrative (1) | 81,666 | 81,592 | 290,116 | 267,909 | ||||||||||||
| Total operating expenses | 146,913 | 206,476 | 479,169 | 540,172 | ||||||||||||
| Loss from operations | (15,301 | ) | (85,899 | ) | (125,782 | ) | (219,424 | ) | ||||||||
| Interest income, net | 129 | 1,242 | 462 | 6,056 | ||||||||||||
| Other income (expense) | 383 | (202 | ) | 706 | (1,262 | ) | ||||||||||
| Loss before income taxes | (14,789 | ) | (84,859 | ) | (124,614 | ) | (214,630 | ) | ||||||||
| Income tax expense | (332 | ) | (199 | ) | 162 | 194 | ||||||||||
| Net loss | $ | (14,457 | ) | $ | (84,660 | ) | $ | (124,776 | ) | $ | (214,824 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.09 | ) | $ | (0.54 | ) | $ | (0.78 | ) | $ | (1.37 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 160,663 | 158,129 | 159,651 | 156,683 | ||||||||||||
| (1) Includes the following stock-based compensation expense | ||||||||||||||||
| Cost of product sales, license fees and royalties | $ | 439 | $ | 495 | $ | 1,025 | $ | 2,087 | ||||||||
| Research and development | $ | 5,176 | $ | 7,953 | $ | 17,325 | $ | 23,645 | ||||||||
| Selling, general and administrative | $ | 9,931 | $ | 12,924 | $ | 32,385 | $ | 37,495 |
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30, 2021 | December 31, 2020 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Cash, cash equivalents and investment securities | $ | 540,291 | $ | 631,958 | ||||
| Accounts receivable, net | 60,696 | 48,247 | ||||||
| Interest and other receivables | 972 | 2,035 | ||||||
| Inventory | 14,336 | 9,682 | ||||||
| Prepaid expenses | 24,622 | 25,694 | ||||||
| Total current assets | 640,917 | 717,616 | ||||||
| Property and equipment, net | 8,581 | 9,161 | ||||||
| Operating lease right-of-use assets | 60,032 | 47,283 | ||||||
| Restricted cash | 5,770 | 5,770 | ||||||
| Other assets | 2,373 | 2,786 | ||||||
| Total assets | $ | 717,673 | $ | 782,616 | ||||
| Liabilities and stockholders' equity | ||||||||
| Accounts payable | $ | 7,722 | $ | 8,493 | ||||
| Accrued liabilities | 80,496 | 97,474 | ||||||
| Total current liabilities | 88,218 | 105,967 | ||||||
| Operating lease liabilities | 57,677 | 44,460 | ||||||
| Other long-term liabilities | 4,823 | 5,180 | ||||||
| Total liabilities | 150,718 | 155,607 | ||||||
| Total stockholders' equity | 566,955 | 627,009 | ||||||
| Total liabilities and stockholders' equity | $ | 717,673 | $ | 782,616 |
Acadia Pharmaceuticals Inc.
Acadia Pharmaceuticals Inc.